The final analysis of Pfizer and BioNTech's COVID-19 clinical trial data demonstrates it is 95 percent effective and has consistent results across "age, gender, race and ethnicity demographics," which is a slight improvement over the interim data it announced on Nov. 9 showing the vaccine had an efficacy of more than 90 percent.
The Wednesday morning statement said the Phase 3 study “has met all primary efficacy endpoints" and achieved the safety milestone required for the FDA's Emergency Use Authorization, which they plan to submit a request for "within days."
"To date, no serious safety concerns related to the vaccine candidate have been reported,” the companies said.
It may be worth noting (though it won’t be) that only 10 severe cases of #Covid were found in the trial’s 44,000 participants. It would be nice to know how long the average participant was followed to get some sense of a one-year risk ratio for severe disease...— Alex Berenson (@AlexBerenson) November 18, 2020
- Primary efficacy analysis demonstrates BNT162b2 to be 95% effective against COVID-19 beginning 28 days after the first dose;170 confirmed cases of COVID-19 were evaluated, with 162 observed in the placebo group versus 8 in the vaccine group
- Efficacy was consistent across age, gender, race and ethnicity demographics; observed efficacy in adults over 65 years of age was over 94%
- Safety data milestone required by U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) has been achieved
- Data demonstrate vaccine was well tolerated across all populations with over 43,000 participants enrolled; no serious safety concerns observed; the only Grade 3 adverse event greater than 2% in frequency was fatigue at 3.8% and headache at 2.0%
- Companies plan to submit within days to the FDA for EUA and share data with other regulatory agencies around the globe
- The companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021
- Pfizer is confident in its vast experience, expertise and existing cold-chain infrastructure to distribute the vaccine around the world (Pfizer)
“The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic. We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world,” Dr. Albert Bourla, Pfizer Chairman and CEO, said in a statement. “With hundreds of thousands of people around the globe infected every day, we urgently need to get a safe and effective vaccine to the world.”
Ugur Sahin, M.D., CEO and Co-founder of BioNTech, said their original objective was to develop a vaccine "that would generate rapid and potent protection against COVID-19 with a benign tolerability profile across all ages."
"We believe we have achieved this with our vaccine candidate BNT162b2 in all age groups studied so far and look forward to sharing further details with the regulatory authorities," Sahin added.